# K950944: Ambulatory (Holter) Recording System

- Pathway: 510(k) (Traditional)
- Applicant: Biosensor Corp.
- Decided: Jun 18, 1996 after 487 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
105 later devices descend from it; 4 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993617: Digitrakplus Holter Recorder (1999), 62 descendants of its own
- K032466: Spiderview (2003), 56 descendants of its own
- K042108: Vista Plus (2005), 46 descendants of its own
- K993618: DXP1000 Holter Recorder (1999), 43 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own

Source page: https://510kreport.com/device/K950944
Methodology: https://510kreport.com/methodology